A randomised, double-blind, placebo-controlled trial to evaluate the role of intracoronary injection of progenitor cells compared to placebo injection in patients with Dilated Cardiomyopathy who have been pre-treated with G-CSF (Granocyte™) injections for 5 days, and patients treated with a 5 day course of G-CSF (Granocyte™) injection only compared to placebo injection

Randomised Controlled Trial to Compare the Effects of G-CSF (Granocyte™) and Autologous Bone Marrow Progenitor Cells on Quality of Life and Left Ventricular Function in Patients With Idiopathic Dilated Cardiomyopathy

Half the patients will be randomised to the non-interventional part of the trial. In this subgroup of patients will be randomised 1:1 to 5 day course of subcutaneous placebo injections or a 5 day course of G-CSF(Granocyte™) subcutaneous injections

Drug: granulocyte colony stimulating factor (GCSF)

10mcg/kg per day 5 days

Other Name: Lenograstim, Granocyte™, Chugai Pharma UK, Limited

Experimental: Interventional arm

In the subgroup of the interventional arm patients will be randomised 1:1 to receive a 5 day course of subcutaneous G-CSF (Granocyte™) injections and bone marrow aspiration at day 5, they will then receive either stem cells or placebo via intracoronary injection

Procedure: bone marrow mononuclear cells

intra coronary injection of stem cells or placebo

Eligibility

Ages Eligible for Study:

18 Years to 80 Years (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Symptomatic patients with a confirmed diagnosis of dilated cardiomyopathy (NYHA II-III) attending their local 'Heart Failure clinic' who are on optimal heart failure treatment, under supervision from their physician or heart failure nurse specialist, and have no other treatment options

Patients who are NYHA II that have been hospitalised with a dilated cardiomyopathy related condition

Coronary angiography will be performed where necessary to confirm the diagnosis and ensure no other conventional treatment options are indicated

Prior to recruitment to the study patients at risk of ventricular arrhythmia will have undergone electrophysiological assessment and appropriate clinical management (including implantable defibrillator insertion) where indicated (as per NICE guidelines)

Serious known concomitant disease with a life expectancy of less than one year

Follow-up impossible (no fixed abode, etc)

Patients with an irregular heart rhythm (AF allowed if paced in a regular rhythm)

Patients with renal impairment (Creatinine >200mmol/L)

Neoplastic disease without documented remission within the past 5 years

Weight>140kg

Subjects of childbearing potential

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01302171